Senior Clinical Risk Manager

hace 1 semana

Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completo

Overview



Fortrea is a leading contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

Our team transforms drug and device development for partners and patients across the globe by ensuring the swift delivery of life-changing ideas and therapies to those in need.

About the Role



Salary: R$8,000 - R$12,000 per month

As a Senior Clinical Risk Manager at SAO Fortrea Brazil Limitada, you will play a critical role in ensuring the full implementation of risk plans and recommending appropriate changes to ongoing monitoring activities.

Key Responsibilities:


  • Collaborate within a matrix environment to communicate proactively internally and externally and across functions with key stakeholders to ensure plans are proactively and effectively executed to meet client expectations;
  • Conduct central monitoring activities and recommend mitigations to project teams and oversee findings at site, subject and study level;
  • Provide necessary support to the study team;
  • Manage portfolio of studies for a Customer and act as a customer point of contact;
  • Collaborate in the development Central Monitoring proposal text and review of costing, contributes to proposal strategy and development;
  • Oversee at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk;
  • Ensure that tracking and status reporting are performed in a timely and accurate manner;
  • Apply data to recommend any required changes;
  • Support PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting;
  • Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels;
  • Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools;
  • Performs ongoing dashboard reviews, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution;
  • Agrees potential changes to monitoring intervention level with project team in line with the applicable plans, and escalates appropriately;
  • Coaches assigned project teams internally and externally to increase the central monitoring competence;
  • Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies;
  • Evaluates and collates process improvement suggestions and submits to leadership;
  • Evaluates and submits ideas and justification for improved systems and tools to leadership;


Main Requirements



To be successful in this role, you should have:


  • University / college degree or post-graduation (life science preferred) from an appropriately accredited institution;
  • Minimum of 7-9 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g. project management, clinical monitoring, data management and informatics;
  • Fluent English;
  • End to End RBQM experience is preferred;


Why Join Us?



At Fortrea, we are passionate about overcoming barriers in clinical trials and revolutionizing the development process. Our unwavering commitment is to ensure the swift delivery of life-changing ideas and therapies to patients in need. If you are a motivated problem-solver and creative thinker who shares our passion, we encourage you to apply for this exciting opportunity. As a member of our exceptional team, you will enjoy a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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